Venclexta for Chronic Lymphocytic Leukemia – Details

As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi)

Review Status

Under Review

Pre Noc Submission

No

NOC Date

September 30, 2016

Manufacturer

AbbVie Corporation

Submitter

AbbVie Corporation

Submission Date

July 10, 2017

Submission Deemed Complete

July 17, 2017

Submission Type

New Indication

Prioritization Requested

Requested and Granted

Stakeholder Input Deadline ‡

July 24, 2017

Check-point meeting

September 7, 2017

pERC Meeting

November 16, 2017

Initial Recommendation Issued

November 30, 2017

Feedback Deadline ‡

December 14, 2017

pERC Reconsideration Meeting (target date)

February 15, 2018

Clarification

The pCODR Expert Review Committee (pERC) was not able to complete its deliberations at the target meeting date of January 18, 2018. pERC will continue its deliberations for venetoclax on February 15, 2018 (new target).

Final Recommendation Issued (target date)

Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.